1. The Manager Metrology is responsible for the definition and application of site Metrology policy to be applied to GxP critical measuring devices.
- Participates in definition and development of Corporate Calibration Policy. Ensures site specific constraints are taken into consideration
- Translates corporate policy into site policies and procedures and ensures their application. Presents and justifies impact of policy changes to Supply Chain Management Committee.
- Ensures that all key site personnel are appropriately trained and applying policies and procedures
Develops and implements certification program for site.
- Establish frequency and tolerances to be applied for certification on GxP critical devices
- Ensure compliance with cGMP guidelines and regulations with respect to certification programs
- Ensures equipment is maintained in certified status. Any changes to equipment are reviewed and evaluated to ascertain whether additional studies, repairs and/or re-certifications are required
- Ensure industry best practices are reflected in departments SOP’s
Writes and reviews SOP’s, certification protocols and reports as required.
- Contributes to the writing of corporate policies for Metrology.
- Presents and justifies changes to site policies and procedures
- Write and/or review standard operating procedures for equipment and procedures throughout the company with respect to metrology
- Ensure that all departmental processes are covered by SOP’s and are maintained as current
- Provides expert review of OQ (Operating Qualifications) protocols and reports as required.
2. Maintains the competency of the Metrology department
- Ensures department has skills and competence required to carry out certifications.
- Trains technical and users on how to apply Metrology principles
- Keeps up to date on industry best practices
Provides expert assistance in selection of equipment or troubleshooting
- Render expert assistance in troubleshooting certification and/or production failures linked to critical devices
- Review equipment specification documents to ensure calibration constraints taken into consideration prior to purchase
- Trains staff in root cause analysis as it pertains to critical devices
3. Decision Capability· Establishing Certification policy for the site
· Develop procedures for calibration/certification for equipment and/or instruments
· Evaluation of skills/competence of technical and/or contract staff performing calibrations.
· Decisions on acceptance or rejection of metrology work.
· Evaluation of test data and results to ensure compliance
· In partnership with Deputy Director, Equipment Maintenance Services & Facilities Management review of calibration budget
4. Points of Contact
- Quality Control on a daily basis
- Production staff on a daily basis
- Quality Assurance on a weekly basis following up on out of tolerance events
- Technical Service Reps on a weekly basis to get technical advise on calibration procedures
- Maintenance as required regarding repairs, updating master data and scheduling special certification
- Contractors as required to evaluate and approve new service providers
- External Calibration Services as required to complete audits and approval of service providers
- Outside Vendors Manage: Air Particles, HEPA Filters, Resistivity (calibration of devices), contractors to extend the workforce
- Internally Managed: Thermometers, Refrigerators, Micrometers, Calibrate (weights and measure, pipettes, air pressure, temperatures, systems, timers, etc.).
Qualifications
Required Qualifications:
•Minimum University degree (Science, Engineering) or relevant College Diploma
•ASQ Certification, or ability to complete ASQ Certification within the first year of service.
•A minimum of five or more years relevant experience in metrology, calibration and/or quality function within a manufacturing environment.
•Demonstrated managerial and leadership abilities.
•Excellent Written, and Verbal communications and interpersonal skills.
•Ability to function as part of a team while motivating technical staff to achieve results.
•Ability to negotiate with users to best define process and instrument tolerances.
•Strong problem solving skills with ability to identify root cause of certification failures or trends.
•Strong organizational skills.
•Experience working with Microprocessor controlled equipment, multi-point Temperature Recorders, PLC’s and PID’s, temperature & pressure devices and calibration instruments and standards.
•In depth knowledge of metrology, calibration, testing and certification of equipment and instruments.
•Statistical Analysis: Ability to conduct trend analysis, interpretations of data so as to show meaningful results of study.
•Scientific report writing techniques to include: writing SOP’s, protocols, monthly reports etc.
Additional Preferred Qualifications include:
- Master in Science
- Experience working with Procal
- Experience working with Autoclaves, Ovens and Fermentors.
- Training in cGMP guidelines